This company has registrations in United States, Brazil, Australia — 3 overseas markets. The China NMPA lookup is still pending.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K214063 | Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle | 2022-06-03 |
| BR | 80199959006 | CÂNULA DE BIÓPSIA TECIDO MOLE SEMI AUTOMÁTICA MODELO 121 | Class II |
| BR | 80199959007 | CÂNULA DE BIÓPSIA TECIDO MOLE AUTOMÁTICA MODELO 111 | Class II |
| BR | 80199959008 | CÂNULA INTRODUTORA COAXIAL MODELO 131 | Class II |